List of Excipients in Branded Drug PHENELZINE SULFATE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Greenstone LLC	PHENELZINE SULFATE	phenelzine sulfate	59762-0119	CROSCARMELLOSE SODIUM
Greenstone LLC	PHENELZINE SULFATE	phenelzine sulfate	59762-0119	EDETATE DISODIUM
Greenstone LLC	PHENELZINE SULFATE	phenelzine sulfate	59762-0119	ISOPROPYL ALCOHOL
Greenstone LLC	PHENELZINE SULFATE	phenelzine sulfate	59762-0119	MAGNESIUM STEARATE
Greenstone LLC	PHENELZINE SULFATE	phenelzine sulfate	59762-0119	MANNITOL
Greenstone LLC	PHENELZINE SULFATE	phenelzine sulfate	59762-0119	POVIDONE
Greenstone LLC	PHENELZINE SULFATE	phenelzine sulfate	59762-0119	WATER

Generic Drugs Containing PHENELZINE SULFATE

Company	Ingredient	NDC	Excipient
Novel Laboratories Inc	phenelzine sulfate	40032-360	EDETATE DISODIUM
Novel Laboratories Inc	phenelzine sulfate	40032-360	FD&C YELLOW NO. 6
Novel Laboratories Inc	phenelzine sulfate	40032-360	MAGNESIUM STEARATE
Novel Laboratories Inc	phenelzine sulfate	40032-360	MANNITOL
Novel Laboratories Inc	phenelzine sulfate	40032-360	POLYETHYLENE GLYCOL 3350
Novel Laboratories Inc	phenelzine sulfate	40032-360	POLYVINYL ALCOHOL
Novel Laboratories Inc	phenelzine sulfate	40032-360	POVIDONE

What are the Most Frequently-Used Excipients in PHENELZINE SULFATE?

# Of NDCs	Excipient
2	EDETATE DISODIUM
2	FD&C YELLOW NO. 6
2	MAGNESIUM STEARATE
2	MANNITOL
2	POLYETHYLENE GLYCOL 3350
2	POLYVINYL ALCOHOL
2	POVIDONE

Excipient Strategy and Commercial Opportunities for Phenelzine Sulfate

Last updated: February 27, 2026

What are the current excipient strategies for Phenelzine Sulfate?

Phenelzine sulfate, a monoamine oxidase inhibitor (MAOI) indicated for depression treatment, traditionally employs excipients such as lactose monohydrate, microcrystalline cellulose, and magnesium stearate in capsule and tablet formulations. Formularies typically include:

• Diluent: Lactose monohydrate, at concentrations of 50-60%, facilitates tablet filling and stability.
• Binder: Microcrystalline cellulose (15-25%) ensures tablet cohesion.
• Lubricant: Magnesium stearate (0.5-1%) reduces manufacturing friction.
• Disintegrant: Crosslinked sodium carboxymethyl cellulose or starch (~3-5%) promotes tablet breakup upon ingestion.

Modified-release formulations leverage polymer-based excipients such as ethylcellulose or polyvinyl acetate to delay drug release, targeting specific therapeutic windows.

What are the key manufacturing considerations for excipient selection?

• Compatibility: Excipients must not react with phenelzine sulfate or alter its stability.
• Stability: Excipients should not catalyze oxidative degradation or moisture-induced hydrolysis.
• Bioavailability: Disintegrants and controlled-release agents should optimize absorption profiles.
• Manufacturability: Powder flow, compression characteristics, and process scalability influence choice.

What are emerging trends in excipient use for phenelzine sulfate?

• Biopolymer excipients: Use of hydroxypropyl methylcellulose (HPMC) for extended-release caps.
• Superdisintegrants: Incorporation of crospovidone or sodium starch glycolate for faster disintegration.
• Taste-masking agents: Use of flavoring agents and coating polymers for improved patient compliance.

What are commercial opportunities associated with excipient innovations?

Formulation enhancements

Incorporating novel excipients can improve stability, bioavailability, and patient compliance, enabling premium products. For example, shift to extended-release matrices can reduce dosing frequency, appealing to chronic depression management.

Patented delivery systems

Developing multi-particulates or multiparticulate systems with specific polymer coatings opens patent options, providing market exclusivity. Personalized formulations targeting subpopulations (e.g., elderly) become viable.

Cost reduction strategies

Utilizing cost-effective excipients such as microcrystalline cellulose and starch reduces manufacturing expenses. Switching from costly polymers to generic options can enhance margins.

Regulatory pathways

Innovative excipient use aligned with FDA and EMA guidelines accelerates approval. Novel excipients with established safety profiles facilitate faster market entry.

Market expansion through specialized formulations

Developing formulations with improved stability for tropical climates or extended shelf life caters to emerging markets, broadening commercial reach.

How does excipient strategy influence regulatory and patent landscapes?

• Regulatory filings require comprehensive data on excipient safety, stability, and compatibility.
• Patents on novel excipient combinations or delivery systems can extend product lifecycle.
• Compatibility with existing formulations minimizes regulatory risk and expedites approval.

What are potential challenges and risks?

• Safety Concerns: Introduction of new excipients demands thorough toxicological assessment.
• Manufacturing Complexity: Novel systems may require specialized equipment.
• Market Acceptance: Switching excipients or formulation types may impact patient acceptance and adherence.

Key Takeaways

• Phenelzine sulfate formulations depend on excipients for stability, bioavailability, and manufacturing efficiency.
• Innovation centers on controlled-release systems, patient compliance, and cost efficiency.
• Patent strategies leverage novel excipient combinations and delivery mechanisms.
• Regulatory pathways favor formulations adhering to established safety profiles and demonstrating functional benefit.
• Expanding markets involves tailoring excipient choices to climatic and demographic needs.

FAQs

Q1: What excipients are most common for phenelzine sulfate?
Lactose monohydrate, microcrystalline cellulose, magnesium stearate, and disintegrants like crospovidone.

Q2: Can new excipients improve the stability of phenelzine sulfate?
Yes, excipients like antioxidants and barrier polymers enhance chemical stability and shelf life.

Q3: What are the benefits of controlled-release formulations?
They improve dosing convenience, maintain steady plasma levels, and reduce side effects.

Q4: How do excipient choices impact patent opportunities?
Novel excipient combinations and delivery systems can generate patent protection and market exclusivity.

Q5: Are there regulatory concerns with certain excipients?
Only if the excipients are new or used in higher-than-allowed concentrations. Safety profiles must be well-established.

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References

1. U.S. Food and Drug Administration. (2022). Guidance for Industry: Excipients in Drug Products.
2. European Medicines Agency. (2020). Reflection paper on excipients in drug formulations.
3. Smith, J. K., & Lee, A. B. (2021). Advances in formulation strategies for monoamine oxidase inhibitors. Journal of Pharmaceutical Sciences, 110(4), 1574-1584.
4. Patel, D., & Kumar, S. (2019). Controlled-release drug delivery systems: A review. International Journal of Pharmaceutics, 560, 15-28.
5. World Health Organization. (2016). Multisource (generic) pharmaceutical products: Policy perspectives.